Medical Device Manufacturer · US , S. Portland , ME

Binax, Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1986

30

Total

30

Cleared

0

Denied

30 devices

26-30 of 30

Cleared Mar 01, 1988

BINAX PROLACTIN IRMA DIAGNOSTIC KIT

Chemistry · 41d

Cleared Nov 20, 1987

BINAX EQUATE STREP B

Microbiology · 119d

Cleared Oct 02, 1987

BINAX L.S. TSH IRMA TEST KIT

Chemistry · 45d

Cleared Aug 05, 1987

BINAX IRMA TOTAL BETA-HCG TEST KIT

Chemistry · 28d

Cleared Dec 22, 1986

Microbiology · 76d